The following data is part of a premarket notification filed by Macro Medical, Inc. with the FDA for Surgical Instrument, Disposable.
| Device ID | K921402 |
| 510k Number | K921402 |
| Device Name: | SURGICAL INSTRUMENT, DISPOSABLE |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | MACRO MEDICAL, INC. 5179 ST. IMIER DR., SUITE 100 Minneapolis, MN 55421 |
| Contact | Sherry Mcphillips |
| Correspondent | Sherry Mcphillips MACRO MEDICAL, INC. 5179 ST. IMIER DR., SUITE 100 Minneapolis, MN 55421 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-06-04 |